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NCT03345485 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
A Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by Mundipharma Research Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 13
- Study locations
NCT03345485 is a Phase 1 study of Ovarian Cancer and Endometrial Cancer that has completed, run by Mundipharma Research Limited. The registered enrollment target is 71 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (90% lower). The trial reports 13 study locations across 10 states.
The verdict
NCT03345485, a Phase 1 study of Ovarian Cancer and Endometrial Cancer, has completed, sponsored by Mundipharma Research Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 13
- Study locations
Study Summary
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells. The main purpose of this study is to assess the safety, tolerability and efficacy of Tinostamustine in subjects with advanced solid tumours. Subjects will be given Tinostamustine via intravenous infusion on Days 1 and 15 of a 4-week cycle, the dose and infusion time will vary depending on the phase of the study.
Conditions Studied
Interventions
- DRUG Tinostamustine 60mg/m2 over 30min
- DRUG Tinostamustine 80mg/m2 over 30min
- DRUG Tinostamustine 100mg/m2 over 30min
- DRUG Tinostamustine 60mg/m2 over 60min
- DRUG Tinostamustine 80mg/m2 over 60min
Study Locations (13)
Other
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
- Istituto Europeo di Oncologia - Milan
- Erasmus MC Kanker Instituut - Rotterdam
California
- Cedars-Sinai Medical Center - Los Angeles
- Stanford University Medical Center - Palo Alto
Michigan
- University of Michigan - Ann Arbor
New York
- New York University - New York
Texas
- Mary Crowley Cancer Research - Dallas
Ontario, on
- Juravinski Cancer Centre - Hamilton
Quebec
- McGill University - Montreal
Vancouver, BC
- BC Cancer-Vancouver - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2023-03-29 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03345485
The ClinicalTrials.gov registry entry for NCT03345485 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (90% lower). The listed sponsor is Mundipharma Research Limited, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which Tinostamustine 60mg/m2 over 30min is the first listed.
NCT03345485 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT03345485 about?
NCT03345485 is a clinical study titled "Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.". Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells. The main purpose of this study is to assess the safety, tolerability and efficacy of Tin...
What is the current status of trial NCT03345485?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2017-11-08. Estimated completion is 2023-03-29.
What conditions does trial NCT03345485 study?
This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer, Small-cell Lung Cancer, Soft Tissue Sarcoma.
What interventions are being tested in trial NCT03345485?
The interventions under investigation include: Tinostamustine 60mg/m2 over 30min (DRUG), Tinostamustine 80mg/m2 over 30min (DRUG), Tinostamustine 100mg/m2 over 30min (DRUG), Tinostamustine 60mg/m2 over 60min (DRUG), Tinostamustine 80mg/m2 over 60min (DRUG).
Who is sponsoring clinical trial NCT03345485?
This trial is sponsored by Mundipharma Research Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345485 being conducted?
This trial has 13 study locations across California, Michigan, New York, Texas, Ontario, on. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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